News & Analysis as of

OIG Approves Manufacturer’s Direct-to-Patient Discount Sales Program

The Office of Inspector General (“OIG”) recently posted an Advisory Opinion approving a pharmaceutical manufacturer’s direct-to-patient product sales program. While this Advisory Opinion cannot be relied upon by anyone other...more

FDA Issues Draft Guidances for Prior Approval Supplements and Amendments / Easily Correctable Deficiencies Under GDUFA

The Generic Drug User Fee Amendments of 2012 (GDUFA) were signed into law on July 9, 2012, in an effort "to speed access to safe and effective generic drugs to the public and reduce costs to industry." In July 2014, the U.S....more

FDA Issues Draft Guidance on 510(k)

The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued...more

Is Off-Label Drug Promotion Protected Free Speech?

It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more

The Ghosts of Litigation Holds Past

Earlier this year, in the widely followed In re: Actos (Pioglitazone) Products Liability Litigation matter, a Louisiana federal jury ordered a drug manufacturer to pay $6 billion in punitive damages and $1.5 million in actual...more

Recent FDA Draft Guidance Addresses Social Media Challenges Faced by Drug and Device Companies

The first draft guidance discusses how drug and medical device companies may promote their products using character space limited social media (e.g., Twitter) and Internet advertisements (e.g., Google search engine...more

The Inversion Craze: Will Today's Routine Tax Planning Be Retroactively Outlawed?

Alongside the more typical summer fare, such as coverage of the best beach reading and the latest action movie blockbuster, this summer the media have been abuzz with seemingly daily reports on the latest so-called...more

Federal Court Holds Manufacturer of Investigational Drug and Medical Device Responsible for Clinical Trial Investigator’s...

In a recent decision subject to multiple flaws, the United States District Court for the District of Massachusetts refused to dismiss a suit against the manufacturer of an investigational drug and medical device used in a...more

CMS Wants To Shine Light On CME Payments To Physicians

It’s a question CMS has been wrestling with since the enactment of the Sunshine Act (sometimes called the Open Payments Program) as part of the Affordable Care Act. The Sunshine Act generally requires a manufacturer to...more

Drug Compounding: Manufacturing Standards Announced for Outsourcing Facilities

In late 2013, Congress passed the Drug Quality and Security Act (DQSA) in response to a deadly fungal meningitis outbreak linked to a sterile compounded injectable drug shipped across the country and responsible for more than...more

FDA Offers Guidance for Choosing Prescription Drug Names

If you've seen your share of prescription drug commercials, you've likely marveled at the odd drug names: Moexipril. Oxcarbazepine. Zafirlukast. You might think pharmaceutical companies just prefer complex, new combinations...more

Federal Judge Puts Narcolepsy Drug Horizontal Conspiracy Claims to Bed

On Monday, June 23, 2014, a Federal Judge in the Eastern District of Pennsylvania granted summary judgment for five pharmaceutical companies on horizontal conspiracy claims brought by Apotex Inc. and direct purchaser and end...more

FDA Issues Two Draft Guidance Documents Relating to Internet and Social Media Use by Drug and Device Manufacturers

On June 17, 2014, the Food and Drug Administration (“FDA”) released two draft guidance documents related to manufacturer communications on the Internet and social media platforms. The two documents are (1) “Internet/Social...more

Judicial Efficiencies and Economy Support Bifurcation of Liability and Damages at Trial

Endo Pharmaceuticals, Inc. v. Actavis, Inc., et al. Case Number: 1:12-cv-08985-TPG (Dkt.55) - Endo brought suit against Actavis, as well as over a dozen other pharmaceutical manufacturers, for allegedly...more

HRSA “Interprets” Its Enjoined 340 Orphan Drug Rule into Effect

In January, I predicted that 2014 would be a game-changer for the 340B Drug Discount Program, in part because of HRSA’s announcement that, in June 2014, it would for the first time publish an omnibus rule governing 340B...more

FDA Issues Distribution of Risk Information Draft Guidance Amid Asserted Push to Release Guidance on Manufacturer Communications

The U.S. Food and Drug Administration (FDA or the Agency) issued the June 6, 2014, draft guidance (Draft Guidance) in response to stakeholder inquiries into the Agency’s views on disseminating new scientific or medical...more

Genzyme First Circuit Decision

In a huge victory for Massachusetts-based biologics manufacturer Genzyme Corporation, the First Circuit Court of Appeals on June 5, 2014 affirmed the District Court’s dismissal of a multi-million dollar shareholder class...more

The Orphan Drug Wars: HHS’s Recent Loss to PhRMA

On May 27, 2014, almost a year following the promulgation of its final rule, the U.S. Department of Health and Human Services (HHS) had its rule vacated by the U.S. District Court for the District of Columbia under an...more

Recent Court Decision Limits HRSA's Authority Under the 340B Drug Discount Program - Will It Change the Impact of the Anticipated...

In the rapidly evolving landscape of the 340B Drug Discount Program, a recent court decision is the first to limit the rulemaking authority of the Health Resource and Services Administration (HRSA). This decision may...more

FDA Issues Draft Guidance Relating to Distribution of New Risk Information for Approved Drugs and Biologics and Grants Two Citizen...

On June 6, 2014, the Food and Drug Administration (“FDA”) issued two documents that reflect the agency’s ongoing effort to clarify its regulatory approach regarding manufacturer communication of scientific and medical...more

Establishing Personal Jurisdiction Over Foreign Corporations in ANDA Cases

In this BNA Insight, attorney Paul Ragusa examines the impact of a recent U.S. Supreme Court decision on litigation involving foreign corporations and abbreviated new drug applications. He says it may become more challenging...more

Cloudy Skies Ahead for Providers? CMS’ Release of Medicare Billing Data Combined with Physician Payment Sunshine Act Data May...

In February 2013, we reported (on our Healthcare Law Blog) that the Centers for Medicare and Medicaid Services (CMS) announced the final rule for the Physician Payments Sunshine Act. In the interest of providing more...more

FDA Ups the Ante on Inspections with New Administrative Detention Authority

New authority allows FDA inspectors to quickly detain products during inspections if they believe the products are misbranded or adulterated....more

OIG Proposes Rule to Implement Expanded Civil Monetary Penalty Authority under the ACA

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has published a proposed rule that would amend the health care program civil monetary penalty (CMP) regulations (Proposed Rule)....more

FDA Plays Catch Up in the Digital Age

Part of JD Supra's series on innovation and the law. A look at how, as pharmaceutical manufacturers increasingly turn to social media to exchange information, laws and regulations that are decades old struggle to keep pace...more

70 Results
|
View per page
Page: of 3